Product NDC: | 75987-010 |
Proprietary Name: | DUEXIS |
Non Proprietary Name: | Ibuprofen and Famotidine |
Active Ingredient(s): | 26.6; 800 mg/1; mg/1 & nbsp; Ibuprofen and Famotidine |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 75987-010 |
Labeler Name: | Horizon Pharma Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022519 |
Marketing Category: | NDA |
Start Marketing Date: | 20110429 |
Package NDC: | 75987-010-71 |
Package Description: | 15 BLISTER PACK in 1 BLISTER PACK (75987-010-71) > 1 TABLET, COATED in 1 BLISTER PACK |
NDC Code | 75987-010-71 |
Proprietary Name | DUEXIS |
Package Description | 15 BLISTER PACK in 1 BLISTER PACK (75987-010-71) > 1 TABLET, COATED in 1 BLISTER PACK |
Product NDC | 75987-010 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ibuprofen and Famotidine |
Dosage Form Name | TABLET, COATED |
Route Name | ORAL |
Start Marketing Date | 20110429 |
Marketing Category Name | NDA |
Labeler Name | Horizon Pharma Inc. |
Substance Name | FAMOTIDINE; IBUPROFEN |
Strength Number | 26.6; 800 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] |